Patient care often includes use of advanced medical devices. These devices typically automatically perform a host of functions including therapeutic functions, for example, to deliver therapy to a patient or patients, or to perform diagnostic functions such as automatically running tests on patients. These functions are also sometimes referred to as features of the medical devices. Examples of medical devices include, blood glucose meters, insulin pumps, urinalysis devices, fetal heart monitoring devices, blood test meters, sleep apnea or hypopnea detection devices, and sleep apnea therapy devices like continuous positive airway pressure (CPAP) devices, blood pressure cuffs and weight scales. Implantable medical devices (IMDs) are devices designed to be implanted into a patient. Some examples of IMDs include cardiac rhythm management (CRM) devices such as implantable pacemakers and implantable cardioverter defibrillators (ICDs). The devices are used to treat patients using electrical therapy and to aid a physician or caregiver in patient diagnosis through internal monitoring of a patient's condition. IMDs may also include electrical leads that are either separate from, or connected to, a CRM device. Electrical leads connected to CRM devices are typically located in or near a heart to provide electrical therapy to the heart. The electrical leads are also in communication with sense amplifiers of the CRM devices to monitor intrinsic electrical heart activity of a patient. Other examples of IMDs include implantable insulin pumps or devices implanted to administer drugs to a patient. Additionally, some medical devices are able to communicate with other devices by wireless communication signals.
Often, the full functionality of the medical devices is not available or useful to a patient or caregiver. The functions actually needed or used may be a subset of the available functions, such as to match the device to specific patient needs. If the medical device is implantable, a device parameter, device configuration, or patient parameter may change. This, in turn, may require changing the functions available in the medical device.
Additionally, when new functions are developed, the functions may need to be approved by one or more governmental, quasi-governmental, or other regulatory bodies, such as the Food and Drug Administration (FDA) of the United States Government. Gaining regulatory approval is often a long process. For example, it may involve lengthy clinical trials. If an IMD is marketed worldwide, an IMD manufacturer needs to gain approval for the new functions from several regulatory bodies in different geographical areas of the world.